munging metadata

Since starting work on ODMv2 last year the CDISC Data Exchange Standards Team, formerly known as the XML Technologies Team, has made substantial progress towards completing the backlog tasks and updates planned for ODMv2. Much of this work is progressing concurrently, creating a broad set of ongoing discussions. To follow the ODMv2 development work the best place to begin is the ODM-XML page in the XML Tech space on the CDISC Wiki, where you can find a list of the most recently updated pages, a link to the decision log, and links to other relevant aspects of the project. You can also find the notes from our meetings, and if you miss a meeting, a recording of it is available through the notes for a few weeks after the teleconference. The Data Exchange Standards Team's goal for 2018 is to release a first draft of ODMv2 for trial use by the end of year. We then plan to test and revise the draft for final release during 2019. This post, some of which was included in the Q4 201...

Last weekend was the 2nd HL7 FHIR Connectathon (Jan. 14 & 15) that included a Clinical Research Track and the 14th overall FHIR Connectathon. This event was hosted on the Riverwalk in San Antonio and featured over 200 attendees for a weekends worth of hacking. The primary purpose of the Connectathon events is to provide a forum for participants to develop and test software in an informal way. During the previous, inaugural Clinical Research Track < http://wiki.hl7.org/index.php?title=FHIR_Connectathon_13> only two of us participated.  By the end of the weekend we were able to use FHIR resources to demonstrate the pre-populate Medidata Rave-based demographics and concomitant medications CRFs. The Clinical Research Track at the 14th Connectathon generated quite a bit more participation interest with 8 attendees. Representatives from vendors, sponsors, and standards organizations participated. Beyond the pre-population of CRFs using EHR data retrieved using FHIR, sever...

Despite just being released in Q2 of 2014, a number of freely available tools are already available to work with Dataset-XML files. The recently-introduced CDISC Dataset-XML standard enables the interchange of tabular datasets, like SDTM or ADaM, using ODM-based XML, and provides a convenient alternative to SAS V5 XPORT files. Tools supporting Dataset-XML are listed on the publicly accessible CDISC Dataset-XML Resources page on the CDISC Wiki. Early versions of many of these tools were available before Dataset-XML was released as a final standard. The speedy availability of these tools highlights the CDISC community’s culture of innovation as inspired by the availability of machine-readable standards. The availability of software tools with the release of Dataset-XML enabled the FDA to begin planning the "Transport Format for the Submission of Regulatory Study Data” pilot prior to the standard’s final release. In order to test Dataset-XML’s suitability as a replacement for SA...

As part of the work to implement Value Level Metadata in SHARE, as well as to author a Define-XML Implementation Guide article, this will be the first of a series of posts on the topic of Value Level Metadata. These posts target a more technical audience, however the Define-XML IG article will include less technical jargon. Future posts will cover additional Value Level Metadata topics and examples. Value Level Metadata (VLM) is metadata that constrains a variable definition based on the value of another variable(s). VLM was originally specified in Define-XML v1.0 as a mechanism for providing the additional metadata needed for software to more accurately interpret these constrained variables.  For example, VSORRES is a variable with structural metadata of  DataType=”Text” and Length=”200”. However, when VSTESTCD=”DIABP” that definition is constrained by VLM to use DataType=”integer” and Length="3". In this case, the value of DIABP in VSTESTCD has triggered the application o...

SHARE wasn't only the theme of this year’s International Interchange, it was also a launch of sorts. CDISC has certainly talked about SHARE at past Interchanges, but this year’s dialogue had a different quality to it. This was largely driven by the fact that the wrappers were taken off the SHARE software, and attendees actually got a preview of what’s coming. We’re still talking about the vision for SHARE, maybe more than ever, but we’re also talking specific features and functions, as well as when we’ll begin using the application. During the SHARE session on Thursday the SHARE Road Map was presented, the version of SHARE currently under development was demonstrated, and we saw how SHARE and CFAST fit together.  The release of SHARE R1 is planned for the first quarter of 2014. After initiating the project in 2007, and following a longish gestation period, the implementation is on target to deliver in a period of just under 6 months. We have a long way to go to fully realize t...